Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Xcyte Therapies |
---|---|
Information provided by: | Xcyte Therapies |
ClinicalTrials.gov Identifier: | NCT00081783 |
This is a Phase II single arm study of a novel T cell immunotherapy in patients with indolent non-Hodgkin’s lymphoma (NHL). Eligible patients will have relapsed or refractory disease after receiving at least one and no more than four prior regimens. Patients will receive Xcellerated T CellsTM, an ex vivo activated and expanded autologous T cell product, in an attempt to enhance immune responses with anti-tumor activity. The primary endpoint of the study is to evaluate the efficacy of Xcellerated T Cells in patients with indolent NHL.
Secondary endpoints are to evaluate the safety of the therapy in this patient population, and to evaluate changes in the number and phenotype of T- and B-lymphocytes, as well as changes in the T cell receptor repertoire, hemoglobin levels, platelet counts and quantitative immunoglobulin levels. In a subset of patients, fine-needle aspirates of malignant lymph nodes will be performed to assess changes in the lymphocyte composition and phenotype. Bone marrow aspirates will be similarly evaluated. Finally, anti-tumor immune responses will be evaluated in patients amenable to biopsy of enlarged lymph nodes.
Condition | Intervention | Phase |
---|---|---|
Non-Hodgkin's Lymphoma |
Drug: Xcellerated T Cells |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Xcellerated T CellsTM in Patients With Relapsed or Refractory Indolent Non-Hodgkin’s Lymphoma (NHL) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Scans will be obtained at baseline, following registration.
Exclusion Criteria:
Contact: Vicki M. Mizuno | 206-262-6251 | vmizuno@xcytetherapies.com |
United States, California | |
University of California, San Francisco | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Jenny Zhang 415-476-3741 jzhang@medicine.ucsf.edu | |
Principal Investigator: Lawrence D. Kaplan, MD | |
California Cancer Care | Recruiting |
Greenbrae, California, United States, 94904 | |
Contact: Jaime Chang 415-925-5040 JChang@cal-cancer-care.com | |
Principal Investigator: Jennifer B. Lucas, MD | |
Sharp Memorial Hospital | Recruiting |
San Diego, California, United States, 92123 | |
Contact: Cathy Wood 858-939-5062 cathy.wood@sharp.com | |
Principal Investigator: Charles Redfern, MD | |
University of California, San Diego | Recruiting |
San Diego, California, United States, 92093 | |
Contact: Vineeta Prasad 858-822-0337 vprasad@ucsd.edu | |
Principal Investigator: Januario E. Castro, MD | |
University of Southern California | Not yet recruiting |
Los Angeles, California, United States, 90033 | |
Contact: Lynne Smith 323-865-0371 diansmi@usc.edu | |
Principal Investigator: Ann Mohrbacher, MD | |
United States, Colorado | |
Rocky Mountain Cancer Centers | Recruiting |
Denver, Colorado, United States, 80218 | |
Contact: Juli Murphy, BS, CCRC 303-285-5087 juli.murphy@usoncology.com | |
Principal Investigator: Peter McSweeney, MD | |
United States, Georgia | |
Atlanta Cancer Care | Recruiting |
Roswell, Georgia, United States, 30342 | |
Contact: Kathy Andrews 404-851-2359 kandrews@atlantacancercare.com | |
Principal Investigator: Ronald G. Steis, MD | |
United States, Maryland | |
Center for Cancer & Blood Disorders | Recruiting |
Bethesda, Maryland, United States, 20817 | |
Contact: Natalie Bongiorno, RN, BSN 301-571-0019 nbongiorno@ccbdmd.com | |
Principal Investigator: Ralph V. Boccia, MD | |
Johns Hopkins University | Recruiting |
Baltimore, Maryland, United States, 21231 | |
Contact: Susan Newton, RN 410-502-7985 meusesu@jhmi.edu | |
Principal Investigator: Ian W. Flinn, MD, PhD | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Richard Boyajian 617-632-3352 ext 42314 Richard_Boyajian@dfci.harvard.edu | |
Principal Investigator: Arnold Freedman, MD | |
United States, Missouri | |
Washington University | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Kelly Bryan 314-362-6359 kbryan@im.wustl.edu | |
Principal Investigator: Nancy L. Bartlett, MD | |
United States, New Jersey | |
Cancer Institute of New Jersey | Recruiting |
New Brunswick, New Jersey, United States, 08903 | |
Contact: John Martin 732-235-8995 martinj4@umdnj.edu | |
Principal Investigator: Roger K. Strair, MD, PhD | |
United States, Ohio | |
Ohio State University | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Mary Weiss 614-293-3437 Weiss-3@medctr.osu.edu | |
Principal Investigator: Thomas Lin, MD | |
United States, Oregon | |
Oregon Health Sciences University | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Aubyn Grant, CCRP 503-494-5074 granta@ohsu.edu | |
Principal Investigator: Brandon Hayes-Lattin, MD | |
United States, South Carolina | |
Cancer Centers of the Carolinas | Recruiting |
Greenville, South Carolina, United States, 29605 | |
Contact: Kim Williams, RN 864-241-6251 kimberly.williams@usoncology.com | |
Principal Investigator: Joe J. Stephenson, MD | |
United States, Texas | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Ana Ayala 713-792-3610 abayala@mdanderson.org | |
Principal Investigator: Peter W. McLaughlin, MD | |
United States, Washington | |
Swedish Cancer Institute | Recruiting |
Seattle, Washington, United States, 98104 | |
Contact: Toni Oien, CCRC 206-386-2831 toni.oien@swedish.org | |
Principal Investigator: Michael S. Milder, MD | |
Virginia Mason | Recruiting |
Seattle, Washington, United States, 98111 | |
Contact: Aimee Perrault-Gray 206-583-6559 ext 61870 Aimee.PerraultGray@vmmc.org | |
Principal Investigator: David M. Aboulafia, MD |
Study Chair: | Mark W. Frohlich, MD | Xcyte Therapies |
Study ID Numbers: | XT009 |
Study First Received: | April 20, 2004 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00081783 History of Changes |
Health Authority: | United States: Food and Drug Administration |
T Cells Immunotherapy NHL Xcellerated T Cells |
Lymphoma, Small Cleaved-cell, Diffuse Lymphatic Diseases Immunoproliferative Disorders |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |